Support needs of children and family members following discharge from the paediatric intensive care unit (PICU) Other
Conditions
Interventions
Current interventions as of 18/01/2022:
This is a multi-centre longitudinal mixed-methods study of children and their families’ outcomes and support needs in the first-year post-PICU. This will invo
WP2 – qualitative study.
Setting and sampling:
Participants for this study include: (1) child PICU survivors
(2) parents/legal guardians
(3) siblings. Participants will be recruited from five PICUs in Children’s Hospitals across England.These sites include: Nottingham University Hospitals NHS Trust
Birmingham Women and Children’s Hospital NHS Foundation Trust
University Hospitals of Bristol NHS Trust
Great Ormond Street Hospital NHS Foundation Trust
Alder hey Children’s NHS Foundation Trust. They have been selected as sites for this study as they vary in unit size, case mix, geographical location, and patient demographic.
Work-package 1:
A conse
Sponsors
Nottingham University Hospitals NHS Trust
Eligibility
Sex/Gender
All
Age
1 Months to 17 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 18/01/2022: Child: 1. Aged 1 month (and >=44 weeks corrected gestational age) to 17 years at the point of PICU admission 2. Will be discharged alive from the PICU in next 48 hours 3. PICU total length of stay (LOS) >=48 hours at point of discharge in which the patient received PICU therapies for organ dysfunction (including any of the following invasive mechanical ventilation, vasopressors /inotropes, acute renal replacement therapy, or other extracorporeal life support) 4. At least one parent/legal guardian (>=18 years of age or considered emancipated) living with the potential subject Parent: 1. Parent or legal guardian 2. Cohabits with the child Sibling: 1. Aged >=8 years 2. Is a sibling of the children PICU survivor 3. Cohabits with the child PICU survivor for at least 50% of the time 4. Can independently self-report _____ Previous inclusion criteria: Child: 1. Aged 1 month (and > = 44 weeks corrected gestational age) to 17 years at the point of PICU admission 2. Will be discharged alive from the PICU in next 48 hours 3. PICU total length of stay (LOS) > = 72 hours at point of discharge in which the patient received PICU therapies for organ dysfunction (including any of the following invasive mechanical ventilation, vasopressors /inotropes, acute renal replacement therapy, or other extracorporeal life support) 4. At least one parent/legal guardian (> = 18 years of age or considered emancipated) living with the potential subject Parent: 1. Parent or legal guardian 2. Cohabits with the child Sibling: 1. Aged > = 8 years 2. Is a sibling of the children PICU survivor 3. Cohabits with the child PICU survivor for at least 50% of the time 4. Can independently self-report
Exclusion criteria
Exclusion criteria: Child: 1. Previously had a Paediatric ICU/Neonatal ICU admission 2. Active do not resuscitate plan/end of life pathway 3. Child in foster care or under the power of Wardship Any participant unwilling or unable (i.e. lacking capacity) to provide consent assent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Child PICU participants: Quality of life measured using the PedsQL™ 4.0 (Pediatric Quality of Life Inventory) Generic Core Scales and Infant Scales – Acute Version at baseline, PICU discharge, 1 month, 3 months, 6 months, and 12 months Parent/legal guardian participants: Quality of life and functioning measured using PedsQL™ Family Impact Module at PICU discharge, 1 month, 3 months, 6 months, and 12 months Sibling participants: Quality of life measured using the PedsQL™ 4.0 (Pediatric Quality of Life Inventory) Generic Core Scales– Acute Version at PICU discharge, 1 month, 3 months, 6 months, and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 16/12/2020: Child PICU participants: 1. Fatigue measured using the PedsQL™ Multi-dimensional Fatigue Scale at baseline, PICU discharge, 1 month, 3 months, 6 months, and 12 months 2. Pain measured using PedsQL™ Pediatric Pain Questionnaire at PICU discharge, 1 month, 3 months, 6 months, and 12 months 3. Functional status that includes mental status, sensory, communication, motor function, feeding and respiratory measured using the Functional Status Scale (FSS) at baseline, PICU discharge, 1 month, 3 months, 6 months, and 12 months 4. Cognitive impairment and functional morbidity measured by using the Paediatric Cerebral Performance Category (PCPC) and the Paediatric Overall Performance Category (POPC) at baseline, PICU discharge, 1 month, 3 months, 6 months, and 12 months 5. Emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and pro-social behaviour measured using the Strengths and Difficulties Questionnaire (SDQ) at PICU discharge, 1 month, 3 months, 6 months, and 12 months 6. Post-traumatic stress symptoms measured using the Child Revised Impact of Events Scale (CRIES-8), Young Child PTSD Screen (YCPS) and Child and Adolescent PTSD screen at 3 months, 6 months and 12 months 7. Perceptions that the participants’ goals can be met, measured using the Children’s Hope Scale (CHS) at PICU discharge, 1 month, 3 months, 6 months, and 12 months Parent/legal guardian participants: 1. Symptoms of anxiety measured using State-Trait Anxiety Inventory 6 (STAI-6) at PICU discharge, 1 month, 3 months, 6 months, and 12 months 2. Depression and anxiety measured using the Patient Health Questionnaire-4 (PHQ-4) at PICU discharge, 1 month, 3 months, 6 months, and 12 months 3. The presence and severity of post-traumatic stress disorder symptoms measured using the Post Traumatic Stress Disorder (PTSD) Checklist for DSM-5 (PCL-5) at 3 months, 6 months, and 12 months Sibling participants: 1. Emotional symp | — |
Countries
England, United Kingdom
Outcome results
None listed